R13-243819 For web publication - was appendix 5 of ARGPM - Pre-submission meetings with the TGA

Pre-submission meetings with the TGA

This guidance is for sponsors preparing applications for therapeutic goods to be entered into the ARTG.

It describes the process and procedures for meetings held at the TGA between sponsors of therapeutic goods and TGA officers in relation to submitting applications to enter therapeutic goods in the ARTG.

The benefits of pre-submission meetings[Punyel1]

Describes thebenefits of pre-submission meetings.

Identifies the types of applications and therapeutic goods that would be ideally suited for pre-submission meetings.

How to request and prepare for a pre-submission meeting[Watede2]

Provides guidance to sponsors on:

  • what to do when considering a pre-submission meeting
  • how to request a pre-submission meeting
  • how to prepare for a pre-submission meeting
  • what to do if a pre-submission meeting needs to be rescheduled
  • how the TGA responds to requests for pre-submission meetings

How pre-submission meetings are conducted[Watede3]

Provides guidance on how the meetings are conducted and recorded.

What happens after pre-submission meetings[Watede4]

Providesinformation on what happens after the meeting with receiving and acknowledging the meeting record.

Proformas to assist with pre-submission meetings

Includes the following forms to assist sponsors to obtain maximum benefit from pre-submission meetings:

  • Requesting pre-submission meetings
  • Preparing a meeting dossier of information for the meeting
  • Recording the main discussion points and outcomes of the meeting[Watede5].

The benefits of pre-submission meetings

Meetings can be beneficial for both the sponsors and TGA to:

  • provide a consistent and transparent approach to obtaining an common understanding of:

-the therapeutic good

-what is required for evaluation and the evaluation process

-any issues that may need to be resolved prior to submitting applications

  • enable the sponsor and TGA to plan for the submission to manage timeframes and resources required for evaluation.

Pre-submission meetings are most beneficial for:

  • complex therapeutic goods
  • new or emerging technologies
  • combination of technologies (e.g. a medicine device combination product)
  • specificregulatory issues for therapeutic goods that have multiple applications.

How to request and prepare for a pre-submission meeting

What to do when considering a pre-submission meeting

Before contacting the TGA to request a meeting:

refer to the TGA website for any relevant guidance documents from the TGA and European Union guidelines that have been adopted by the TGA as these may address many issues relating to product development

consider whether the concerns can be more effectively addressed by other means such as

-a phone call or, written correspondence to the TGA for guidance about specific requirements for applications

-professional assistance form a regulatory affairs consultant.

How to request a meeting

  • complete the meeting request proforma[Watede6]and attach to an email
  • send the email at least four (4) weeks before the proposed meeting date to one of the following:

–For prescription medicines - the TGA case manager at

–For other therapeutic goods, the relevant office in TGA for OTC medicines, complementary medicines, medical devices, biologicals

  • include sufficient information for the TGA to:

–determine whether a meeting or an alternative method would better suit the particular situations; and if a meeting is the best approach:

-arrange for TGA staff with the relevant expertise to particulate in the meeting.

  • decide whether you would prefer the meeting to be conducted by teleconference, video conference or by visiting the TGA in person
  • make the arrangements for the meeting (i.e. arrange for the teleconference, videoconferences or arrange your travel).
  • allow approximately 1-2hours for the meeting.

How to prepare for the meeting

To ensure that both the sponsor and the TGA gain maximum benefit from the meeting:

  • Prepare a meeting dossier. The meeting dossier proforma[Punyel7]should assist you to prepare for and obtain the maximum benefit from the meeting.
  • Email the meeting dossier to:

-the TGA case manager for prescription medicines

-contact email address for other therapeutic goods ( OTC medicines, medical devices, biologicals) two (2) weeks before the meeting.

Organising the meeting dossier

The meeting will be more efficient and effective if you:

  • organise the dossier content according to the proposed agenda
  • number the pages sequentially (individual sections can be numbered separately)
  • include a table of contents, appendices, cross-references and tabs differentiating sections.
The content of a meeting dossier for pre-submission meetings

Include, for the meeting agenda:

  • a summary of the information relevant to the therapeutic good and any supplementary information relevant to the objectives of the meeting
  • any relevant summarised material that describes results of relevant studies; clinical trials with a sufficientdegree of quantification an explanation for any product development plan that deviates from current guidelines or practices
  • any known issues with the design or evidence for the therapeutic good (for example, the use of a surrogate end point, reliance on a single study use of a non inferiority design, adaptive designs).

Please do not include detailed data, full study and trial reports.

Rescheduling or cancellation

Wherever possible, please avoid rescheduling or cancelling meetings(unless the meeting is no longer necessary) and notify the TGA as soon as possible if a meeting needs to be rescheduled or cancelled. This enables the TGA to give advanced notice to any TGA participants who may be located interstate.

The TGA’s response to a request for a meeting

The TGA encourages pre-submission meetings, however there are occasions when a meetingcould be premature or the issues could be more easily resolved without needing a meeting.

The TGA responds to requests and, if a meeting is the best option, theTGA will schedule a mutually acceptable time and date.

The TGA does not generally reschedule or cancel the meeting, unless there are extenuating circumstances such as:

  • the meeting dossier and agenda is not received in sufficient time (2 weeks) to review the information
  • themeeting dossier does not contain sufficient information to enable the TGA to provide the guidance needed.

How pre-submission meetings are conducted

A TGA officer facilitates the meeting and will usually begin with:

  • clarifying the purpose and goals of the meeting
  • clarifying that the meeting is not to used for a promotional presentation of the dossier.

Meeting record

Although there are no formal minutes of the meetings, the TGA requests the sponsor/applicant initiating the meeting to take a record of the meeting using the meeting record proforma[Punyel8]and provide the summary that clarifies the agreed meeting outcomes, and any actions arising.

Before the end of the meeting, participants will have an opportunity to summarise the important discussion points, agreements, clarifications and action items.

What happens after pre-submission meetings

The sponsor/applicant provides a copy of the meeting record to all participants within two (2) weeks of the meeting and the TGA will acknowledge receipt of the meeting record within 2 weeks of receipt.

It is important to be aware that as knowledge evolves over time, guidance from the TGA may become out of date or be superseded. For this reason any guidance given by the TGA at the pre-submission meeting is nonbinding and is given without prejudice.

Office use only

Request for Pre-submission meeting

Applicant / Sponsor

Company
Address

Contact person

Name
Position
Mailing address
Phone number
Email address

Proposed scheduling information

Proposed date
Proposed time
Proposed meeting length / (max. 2 hours)

Proposed meeting type (tick more than one box if applicable):

In person Teleconference Videoconference

Note: The organisation and scheduling of a teleconference or videoconference is the responsibility of the applicant.

Additional facilities required:

Computer Projector Other (please specify)

Subject matter for discussion

Product type:

Medicine Device Biological Other (please specify)

Include details below, where applicable

Generic name
Trade name
Substance name
Dosage form(s)
Other relevant information
Name
Signature / Date

Background information

  1. Proposed agenda
  2. Overview of the product and its development program (quality, nonclinical, and clinical)

Include a brief background to the disease that the product is supposed to treat, the place of this product in the treatment algorithm and any relevant regulatory history.

  1. Purpose and objectives of the meeting

Include a:

(a)brief statement of the purpose and objectives of the meeting;

(b)description of the issues underlying the agenda; and

(c)summary of:

  1. completed or planned studies;
  2. clinical trials or data that the sponsor/applicant intends to discuss at the meeting;
  3. the general nature of the critical questions to be asked; and
  4. where the meeting fits in overall development plans.

Although the statement should not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarises major results.

  1. List of questions

Include a list of proposed questions, grouped by discipline, with a brief explanation of the context and purpose of each question.

  1. List of participants

Include a list of individuals, including titles and affiliations, from the sponsors /applicant’s organisation or consultants who will attend the proposed meeting.

Include any requests for particular TGA staff or disciplines to participate in the proposed meeting. These people may not attend but are represented.

Office use only

Pre-submission meeting dossier requirements

Applicant / Sponsor

Company
Address

Contact person

Name
Position
Mailing address
Phone number
Email address

Subject matter for discussion

Product type:

Medicine Device Biological Other (please specify)

Include details below, where applicable

Generic name
Trade name
Substance name
Dosage form(s)
Other relevant information

Background information

  1. Proposed agenda
  2. Overview of the product and its development program (quality, nonclinical and clinical)

Include a brief background to the disease that the product is supposed to treat, the place of this product in the treatment algorithm and any relevant regulatory history.

  1. Purpose and objectives of the meeting

Include a brief:

(a)statement of the purpose and objectives of the meeting;

(b)description of the issues underlying the agenda; and

(c)summary of:

  1. completed or planned studies;
  2. clinical trials or data that the sponsor/applicant intends to discuss at the meeting;
  3. the general nature of the critical questions to be asked; and
  4. where the meeting fits in overall development plans.

Although the statement should not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarises major results.

  1. List of final questions

Include a list of final questions, grouped by discipline, with a brief explanation of the context and purpose of each question.

  1. Confirmed list of participants

Include a list of individuals confirmed to be attending, including titles and affiliations, from the sponsors’ / applicant’s organisation or consultants.

  1. Presentation

Include a copy of any presentations to be given at the meeting.

Office use only

Pre-submission meeting

Record of discussions

Applicant / Sponsor

Company
Address

Contact person

Name
Position
Mailing address
Phone number
Email address

Meeting information

Meeting date
Location
Start time
Closing time

Subject matter for discussion

Product type:

Medicine Device Biological Other (please specify)

Include details below, where applicable

Generic name
Trade name
Substance name
Dosage form(s)
Other relevant information

Meeting participants

Facilitator / Chair / Secretariat / Minutes
Applicant / External participants / Title / Company position
Table heading / Table heading
TGA participants / Title / position
Table heading / Table heading

Meeting objectives

Discussion points(bullet format)

Outcomes(bullet format)

Unresolved issues, or issues requiring further discussion

[NB: These should result in further correspondence]

Action items

Item # / Item to be actioned / Responsible person / Due date
1
2
3

Attachments/handouts

1

[Punyel1]Hyperlink headings to the relevant text in the guidance

[Watede2]Hyperlink headings to the relevant text in the guidance

[Watede3]Hyperlink headings to the relevant text in the guidance

[Watede4]Hyperlink headings to the relevant text in the guidance

[Watede5]Hyperlink headings to the relevant text in the guidance

[Watede6]Hyperlink to the relevant proforma in the guidance

[Punyel7]Hyperlink to the relevant proforma in the guidance

[Punyel8]Hyperlink to the a meeting record sheet proforma